The exogenous obesity, also named as morbid obesity or other names, generally means a weight increase in a significant proportion according to height, age, etc., that may be a risk for life due to the problems caused by the obesity itself. Before this medical circumstance, diverse medical treatments for weight reduction usually fail, therefore, surgical procedures have remained as the only possibility of treatment with an actual effectiveness, in most of the cases.
The obesity problem is so significant in developed countries that it has been considered as a public health problem, so the most important objective of any therapeutics is trying to solve this ailment with more effective treatments and less complications, less morbi-mortality and lower costs.
During the sixties and seventies, surgical experiences trying to reduce overweight were made and reported, by creating derivations that may produce a short intestine effect, usually having disastrous results, since morbi-mortality was so high that caused almost a total abandonment thereof, until surgical devices appeared such as staplers that arrived to our country at the end of the seventies, early eighties, starting a series of works published throughout the world, mainly about gastroplasties and derivations with a plurality of variations, the results of which were good as to weight control and decrease refer, but open surgery was needed having therefore risks in surgery, anesthesia, etc., in addition to high cost.
More recently, about 5 years ago, a new surgical technique appeared, consisting in placing by laparoscopy, an inflatable band encircling the stomach on its upper part, by means of a subcutaneous valve that may be controlled by radiology and/or endoscopy. Through this technique, a gastric reduction and food intake decrease are produced, resulting in a significant weight loss, practically the same as the one obtained by open surgery with staplers, but with less morbi-mortality and the advantages of the laparoscopic surgery, i.e., less pain and fast postoperative recovery. However, the most important problem of this surgical technique is the cost increase, as it also an hospital, surgical and laparoscopic procedure, in addition to the band cost and experienced surgeons requirement.
At early eighties, the first reports on the use of intragastric balloons for obesity treatment appeared, which partially fill the stomach to produce a feeling of satiety, thus helping to reduce the food intake and to adopt new eating habits. Since then and during the next 10 years, approximately, scientific literature publications of several countries were issued about diverse experiences on the use of balloons made of different materials, most of them reporting failures and very low success percentages, due to many complications and troubles during the placing procedure, handling and surveillance during the treatment period, and therefore, the method lost credibility and in many cases, it was abandoned, except for isolated experiences, reported in diverse publications. Currently, Bioenterics Corporation manufactures and distributes an intragastric balloon named BIB® System, which is seldom used, because the same company recommends it only as an alternative for limited reduction short programs or in some cases, prior to a definitive surgery, for which a gastric capacity reduction surgery via laparascopy is recommended, by applying a gastric band, produced by the same company.
The most significant problems arising from the use of intragastric balloons were, on the one hand, the manufacturing material, because the elements employed at the beginning were easily destroyed by gastric juices, so the balloon should be frequently replaced, however, nowadays this issue has been solved by the use of a resistant silicone material, that is able the stay several months inside the patient. Other important difficulties are the balloon rupture, which consequently causes its migration towards the intestine, eventually causing an intestine obstruction requiring surgery, and also the inflated balloon migration causing injuries to gastric mucous and the esophagus or pylorus obstruction. Even more, the balloons available at the market, show a great technical difficulty for endoscopic placing and the inflating maintenance or modification, once it has been placed into the stomach.
There are several documents describing intragastric balloons with improvements intended to overcome some of these inconveniences, including the one described in U.S. Pat. No. 5,259,399 of Alan Brown, consisting in a balloon that is placed at the stomach fundus by means of a percutaneous gastronomy and it is fixed to the patient's skin, with a rigid or semi-rigid thick device, introducing the balloon there trough which is then inflated and deflated with solutions and controlled by sensors placed on the patient's body and a battery driven electric pump driven placed out of the patient's body. The disadvantage of this device is that patient must suffer a probe or thick catheter out of the abdomen skin and such probe or catheter has to be connected to the inflating or deflating equipment each time any food is ingested, resulting very uncomfortable for the patient.
On the other hand, U.S. Pat. No. 5,234,454 by Roger G. Bangs, describes an intragastric balloon placed through a surgical gastrostomy previously made (several weeks before), to place the balloon later, implying a prior surgery. In addition, the used probe is very thick, approximately 1 cm diameter or more, and it stays externally, which means that the patient must have a probe out of his/her body through a puncture made in the abdominal wall, which, in addition to the inconvenience found in the Alan Brown US Patent, causes constant pain and discomfort to the patient. Bangs' device has two balloons, one to be inflated and maintain the stomach placed against the abdominal wall on the inside and a distal balloon, used to fill the stomach.
Mexican Patent Application No. PA/a/2000/001922, corresponding to U.S. Patent Application No. 2001/0037127 A1 of Andres de Hoyos Garza, describes a catheter of percutaneous, intragastric balloon for obesity treatment, consisting in a modification to the endoscopic percutaneous gastrostomy probe which has been modified in its proximal or intragastric end, by being provided with a balloon that is inflated with air to different volumes through an external or extragastric valve by means of a manometer or syringe. The advantage described by the inventor, compared with the prior art is that, it neither moves in the stomach, nor migrates in the event of rupture as it is fixed, and its filling capacity may be controlled externally at any time. A disadvantage found with this system is that it is fixed to the external side of the stomach wall on the skin, then patient must bear external elements, that may be quite annoying. On the other hand, de Hoyos fails to disclosed the way to fix the system and most important, leaks and infections of stomach wall tissues—due to its communication with the stomach—are not contemplated or any how solved.
Likewise, U.S. Patent Application No. 2002/0055757 of Roger de la Torre et al., discloses a Method and a Device to be used in the Placing of a Minimum Invasive Intragastric Device, such device describes an expandable component and fasteners such as sutures, this device is partially extended through the stomach wall and fastened or anchored in the patient's stomach. The device may be spread out or removed by an transesophageal approach and/or through a combination of transesophageal or transabdominal approaches. This invention fixes the balloon to the stomach and abdominal wall by means of sutures, which may cause tissue necrosis and in a few days leaks, infections or stomach piercing may happen, and once it has been installed within the stomach, the inflating control is not solved.
Likewise U.S. Pat. No. 5,993,473 of Young C. Chang and Mei H. Chan, describes a device of expandable body for gastric cavity, including an elastic expandable body, a rigid and sealed supply filling tube connected to the expandable body and has a fastener and a valve over the base of the supply filling tube. The device proposed by Messrs. Chang and Chan includes several elements disposed outside the abdominal wall with a rigid and wide catheter, which causes great discomfort to the patient and additionally, they do not solve the fixing technique at the abdominal wall.
Therefore, there is a need to have a mean for morbid obesity treatment that reduces the surgical and postoperatory risks, easy to handle and install by a minimum invasive surgery technique, without laparoscopic surgery or any other type, with less anaesthetic or surgical trauma, having an inflating control, producing a significant and controlled weight reduction, similar to current surgical proceedings of gastroplasty derivations and placing of bands, substantially eliminating the discomfort to patient and reducing the current cost of other surgical treatments.